Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data
presented at the American Heart Association (AHA) 2022 Scientific
Sessions relevant to VASCEPA®/VAZKEPA (icosapent ethyl) and patient
care. Important data at the meeting included RESPECT-EPA, A
Randomized Trial for Evaluation in Secondary Prevention Efficacy of
Combination Therapy - Statin and Eicosapentaenoic Acid and
PROMINENT, Pemafibrate to Reduce Cardiovascular Outcomes by
Reducing Triglycerides in Patients with Diabetes Study.
RESPECT-EPA Third Study to Show CV
Benefit Consistent with REDUCE-IT®
and JELIS
The RESPECT-EPA clinical trial is an
independent study funded by the Japanese Heart Foundation.
In 2005, the Japan EPA Lipid Intervention study (JELIS) first
demonstrated a beneficial effect of highly purified
eicosapentaenoic acid (EPA) on cardiovascular outcomes in patients
with or without coronary artery disease (CAD). In 2019, Amarin
published the positive results of its double-blind
placebo-controlled study REDUCE-IT in patients with cardiovascular
risk and elevated TG levels. And now, RESPECT-EPA is the third
study that demonstrated the value of highly purified EPA in
reducing cardiovascular outcomes in patients with CAD.
The late breaking data presented at AHA using
1.8 grams per day of purified EPA is consistent with the
substantial body of evidence from the REDUCE-IT and JELIS
trials, which showed that highly purified prescription EPA
plus statin significantly reduces the risk of cardiovascular events
in high- and very high-risk statin-treated patients.
Importantly, the study achieved a borderline
statistical significance with a 21.5% reduction in the primary
composite endpoint measuring cardiovascular risk (p value 0.054)
and achieved a statistically significant 26.6% reduction in the
secondary composite endpoint of RESPECT-EPA (p value 0.03).1
EPA level matters. In addition,
a post-hoc analysis conducted by the investigators to control for
attained EPA levels yielded a statistically significant 27.5%
reduction in the primary endpoint (p value 0.02). 2
“As a physician, the results of the RESPECT-EPA
trial are directionally consistent with prior outcomes studies of
EPA such as REDUCE-IT in patients with cardiovascular disease,”
said Dr. Payal Kohli, MD, FACC, Assistant Clinical Professor of
Medicine, University of Colorado Anschutz. “This adds to the
growing body of evidence supporting the use of EPA for
cardiovascular risk reduction in patients with well treated LDL-C
and persistent cardiovascular risk.”
Additional key data highlights presented at AHA
Scientific Sessions include:
- The Phase 3
PROMINENT study, simultaneously published in the New England
Journal of Medicine (NEJM), failed to demonstrate a cardiovascular
benefit for pemafibrate in addition to statin therapy in more than
10,000 men and women with type 2 diabetes with a high risk of
cardiovascular disease. Pemafibrate was associated with a higher
incidence of adverse renal events and venous thromboembolism.3,4
The failure of this study is the latest in a series of three failed
cardiovascular outcomes trials, including ACCORD-Lipid and FIELD,
in which fenofibrates and the broader class of fibrate drugs have
failed to demonstrate a cardiovascular benefit for statin-treated
patients with a high risk of cardiovascular disease. Despite
overwhelming evidence that they have not demonstrated any benefit
in reducing cardiovascular risk, fibrates continue to be the second
most commonly prescribed lipid agents after statins, extensively
prescribed for approximately two million Americans annually, most
often along with statins. These realities, coupled with the FDA
previously revoking the approval of fenofibrates in combination
with a statin to reduce cardiovascular risk, should lead to a
change in prescribing practices among physicians to clinically
proven therapies.
- Other data
presented at AHA 2022 support sustained low-density lipoprotein
(LDL) antioxidant effects for EPA in vitro compared with
docosahexaenoic acid (DHA) or mineral oil. The researchers
concluded that the longer-term antioxidant actions of EPA may
contribute to reduced events independent of placebo selection.5
Additional in vitro data presented at the meeting found that
neither mineral oil nor corn oil affected rates of LDL oxidation, a
central mechanism of atherosclerosis, even at high
concentrations.6
“We are very encouraged by the totality of these
data presented at AHA 2022, as they further underscore the clinical
and therapeutic value of VASCEPA/VAZKEPA for clinicians and tens of
millions of patients globally,” said Nabil Abadir, MB. CH.B., SVP,
Chief Medical Officer and Head of Global Medical Affairs, Amarin.
“Clinicians should make the best choice possible for their patients
and should have confidence in VASCEPA as a proven treatment option
on top of statins to reduce CV risk and to help optimize treatment
in appropriate high-risk patients.”
None of the data and analyses highlighted above
were funded by Amarin.
About Amarin
Amarin is an innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. From our foundation
in scientific research to our focus on clinical trials, and now our
commercial expansion, we are evolving and growing rapidly. Amarin
has offices in Bridgewater, New Jersey in the United States, Dublin
in Ireland, Zug in Switzerland, and other countries in Europe as
well as commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the
world. In the United States alone, cardiovascular disease results
in 859,000 deaths per year.7 And the number of deaths in the United
States attributed to cardiovascular disease continues to rise. In
addition, in the United States there are 605,000 new and 200,000
recurrent heart attacks per year (approximately 1 every 40
seconds). Stroke rates are 795,000 per year (approximately 1 every
40 seconds), accounting for 1 of every 19 U.S. deaths. In
aggregate, in the United States alone, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, 1 every 13 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to
reduce a patient’s risk for cardiovascular events, such as heart
attack, stroke or death. However, even with the achievement of
target LDL-C levels, millions of patients still have significant
and persistent risk of cardiovascular events, especially those
patients with elevated triglycerides. Statin therapy has been shown
to control LDL-C, thereby reducing the risk of cardiovascular
events by 25-35%.8 Significant cardiovascular risk remains after
statin therapy. People with elevated triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.9,10,11
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to
evaluate the effect of VASCEPA in adult patients with LDL-C
controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by
statin therapy and various cardiovascular risk factors including
persistent elevated triglycerides between 135-499 mg/dL (median
baseline 216 mg/dL) and either established cardiovascular disease
(secondary prevention cohort) or diabetes mellitus and at least one
other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018,
followed 8,179 patients at over 400 clinical sites in 11 countries
with the largest number of sites located within the United States.
REDUCE-IT was conducted based on a special protocol assessment
agreement with FDA. The design of the REDUCE-IT study was published
in March 2017 in Clinical Cardiology.12 The primary results of
REDUCE-IT were published in The New England Journal of Medicine in
November 2018.13 The total events results of REDUCE-IT were
published in the Journal of the American College of Cardiology in
March 2019.14 These and other publications can be found in the
R&D section on the company’s website at www.amarincorp.com.
About VASCEPA®/VAZKEPA® (icosapent ethyl)
Capsules
VASCEPA capsules are the first prescription treatment approved
by the U.S. Food and Drug Administration (FDA) comprised solely of
the active ingredient, icosapent ethyl, a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed over 18 million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States,
icosapent ethyl is approved and sold in Canada, Lebanon, Germany
and the United Arab Emirates. In Europe, in March 2021 marketing
authorization was granted to icosapent ethyl in the European Union
for the reduction of risk of cardiovascular events in patients at
high cardiovascular risk, under the brand name VAZKEPA. In April
2021 marketing authorization for VAZKEPA (icosapent ethyl) was
granted in Great Britain. The Great Britain Marketing Authorization
for VAZKEPA applies to England, Scotland and Wales.United
StatesIndications and Limitation of
Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated
statin therapy to reduce the risk of myocardial infarction, stroke,
coronary revascularization and unstable angina requiring
hospitalization in adult patients with elevated triglyceride (TG)
levels (≥ 150 mg/dL) and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the
cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent
than placebo): musculoskeletal pain (4% vs 3%), peripheral edema
(7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial
fibrillation (5% vs 4%).
- Common adverse reactions in the
hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Europe
For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe, please click
here.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Forward-Looking Statements
This press release contains forward-looking statements which are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, including beliefs about
the continued failure of fenofibrates and the broader class of
fibrate drugs to demonstrate cardiovascular benefits in
statin-treated patients with a high risk of cardiovascular disease;
the clinically proven benefits of highly purified prescription
eicosapentaenoic acid (EPA) plus statin in significantly reducing
the risk of cardiovascular events in high- and very high-risk
statin-treated patients; and the clinically proven benefits and
overall potential and future success of VASCEPA (marketed as
VAZKEPA in Europe) generally. These forward-looking statements are
not promises or guarantees and involve substantial risks and
uncertainties. A further list and description of these risks,
uncertainties and other risks associated with an investment in
Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including Amarin’s annual report on Form
10-K for the full year ended 2021. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate.
Availability of Other Information About
Amarin
Amarin communicates with its investors and the public using the
company website (www.amarincorp.com) and the investor relations
website (investor.amarincorp.com), including but not limited to
investor presentations and FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact InformationInvestor
Inquiries:Lisa DeFrancescoAmarin Corporation
plcIR@amarincorp.com
Media Inquiries:Mark Marmur Amarin Corporation
plcPR@amarincorp.com
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin
Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark
in Europe and other countries and regions and is pending
registration in the United States.
References
____________________
1 Respect-EPA: Highly purified EPA appears to reduce risks of CV
events in Japanese CAD patients on Statins. American College of
Cardiology.
https://www.acc.org/latest-in-cardiology/articles/2022/11/01/22/00/sun-7pm-respect-epa-aha-2022.
Published November 6, 2022. Accessed November 6, 2022.2
Respect-EPA: Highly purified EPA appears to reduce risks of CV
events in Japanese CAD patients on Statins. American College of
Cardiology.
https://www.acc.org/latest-in-cardiology/articles/2022/11/01/22/00/sun-7pm-respect-epa-aha-2022.
Published November 6, 2022. Accessed November 6, 2022.3 Das Pradhan
A, Glynn RJ, Fruchart J-C, et al. Triglyceride lowering with
pemafibrate to reduce cardiovascular risk. N Engl J Med. 2022 DOI:
10.1056/NEJMoa22106454 Virani SS. A fibrates story-A tepid end to a
Prominent drug. N Engl J Med. 2022 DOI: 10.1056/NEJMe22132085
Sherratt SC, Libby P, Bhatt DL, Mason P. Eicosapentaenoic Acid
(EPA) inhibits low-density lipoprotein (LDL) oxidation compared to
docosahexaenoic acid (DHA) and mineral oil in vitro. Circulation.
2022;146:A13685.6 Sherratt SC, Libby P, Bhatt DL, Mason P. High
concentration mineral oil, corn oil and their constitutive fatty
acids do not influence low-density lipoprotein (LDL) oxidation
rates in vitro. Circulation. 2022;146:A15024.7 American Heart
Association. Heart Disease and Stroke Statistics—2020 Update: A
Report From the American Heart Association. Circulation.
2020;141:e139-e596.8 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.9
Budoff M. Triglycerides and triglyceride-rich lipoproteins in the
causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.10 Toth PP, Granowitz C, Hull M, et al. High
triglycerides are associated with increased cardiovascular events,
medical costs, and resource use: A real-world administrative claims
analysis of statin-treated patients with high residual
cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.11
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563.12 Bhatt DL, Steg PG,
Brinton E, et al., on behalf of the REDUCE-IT Investigators.
Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular
Events with Icosapent Ethyl–Intervention
Trial. Clin Cardiol. 2017;40:138-148.13 Bhatt DL, Steg
PG, Miller M, et al., on behalf of the REDUCE-IT Investigators.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med.
2019;380:11-22.14 Bhatt DL, Steg PG, Miller M, et al., on behalf of
the REDUCE-IT investigators. Effects of Icosapent Ethyl on Total
Ischemic Events: From REDUCE-IT. J Am Coll Cardiol.
2019;73:2791-2802.
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